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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR IVACAFTOR; IVACAFTOR, TEZACAFTOR


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All Clinical Trials for Ivacaftor; Ivacaftor, Tezacaftor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02412111 ↗ A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Respons Completed Vertex Pharmaceuticals Incorporated Phase 3 2015-06-01 This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.
NCT02508207 ↗ A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 2 2016-02-01 To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
NCT02730208 ↗ A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 2 2016-09-01 The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
NCT02951182 ↗ A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis Completed Vertex Pharmaceuticals Incorporated Phase 2 2016-10-01 This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF).
NCT02951195 ↗ A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis Completed Vertex Pharmaceuticals Incorporated Phase 2 2016-11-01 This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).
NCT02953314 ↗ A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF) Completed Vertex Pharmaceuticals Incorporated Phase 3 2016-11-01 This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation.
NCT03140527 ↗ Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis Completed Proteostasis Therapeutics, Inc. Phase 1 2017-04-10 This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups. The first group will enroll HV into a single ascending dose (SAD) treatment group consisting of three cohorts. The second group will enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts. The third group will enroll HV into a food effect (FE) treatment group consisting of one cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group consisting of one cohort. Approximately 76 subjects will be enrolled in Part 1. Part 2 Cohorts 1 through 3 will enroll adult subjects with cystic fibrosis (CF) currently on stable ivacaftor/lumacaftor background therapy for a minimum of three months. Part 2 Cohorts 4 and Cohort 5 will enroll adult subjects with CF not currently receiving cystic fibrosis conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Part 2 Cohort 6 will enroll adult subjects with cystic fibrosis on stable tezacaftor/ivacaftor background therapy. Approximately 104 subjects will be enrolled in Part 2.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ivacaftor; Ivacaftor, Tezacaftor

Condition Name

Condition Name for Ivacaftor; Ivacaftor, Tezacaftor
Intervention Trials
Cystic Fibrosis 40
Cystic Fibrosis Gastrointestinal Disease 1
Cystic Fibrosis in Children 1
Cystic Fibrosis Liver Disease 1
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Condition MeSH

Condition MeSH for Ivacaftor; Ivacaftor, Tezacaftor
Intervention Trials
Cystic Fibrosis 40
Fibrosis 38
Liver Diseases 1
Gastrointestinal Diseases 1
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Clinical Trial Locations for Ivacaftor; Ivacaftor, Tezacaftor

Trials by Country

Trials by Country for Ivacaftor; Ivacaftor, Tezacaftor
Location Trials
United States 472
Canada 30
Australia 24
United Kingdom 23
Germany 19
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Trials by US State

Trials by US State for Ivacaftor; Ivacaftor, Tezacaftor
Location Trials
Texas 20
Ohio 20
Massachusetts 20
California 20
Pennsylvania 20
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Clinical Trial Progress for Ivacaftor; Ivacaftor, Tezacaftor

Clinical Trial Phase

Clinical Trial Phase for Ivacaftor; Ivacaftor, Tezacaftor
Clinical Trial Phase Trials
Phase 4 3
Phase 3 28
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Ivacaftor; Ivacaftor, Tezacaftor
Clinical Trial Phase Trials
Completed 21
Active, not recruiting 8
Recruiting 6
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Clinical Trial Sponsors for Ivacaftor; Ivacaftor, Tezacaftor

Sponsor Name

Sponsor Name for Ivacaftor; Ivacaftor, Tezacaftor
Sponsor Trials
Vertex Pharmaceuticals Incorporated 34
Proteostasis Therapeutics, Inc. 2
University of Alabama at Birmingham 2
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Sponsor Type

Sponsor Type for Ivacaftor; Ivacaftor, Tezacaftor
Sponsor Trials
Industry 37
Other 18
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